Quality Control Analyst 1
The QC Analyst will be part of the Quality team and be responsible for maintaining the operations of the QC laboratory by managing sample receipt, QC standards and reagent inventory as well as lab consumables, and equipment maintenance. The QC Analyst will support various scientific analyses to evaluate the quality of raw materials, in-process materials, and finished goods and ensure compliance with established standards. Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS.
This role will maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines. You will also recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
Also included in the role you will; maintain cGMP compliance in the laboratory and may require work on various projects to improve efficiency or compliance.
You must be willing and able to work on weekends or extended hours as needed and additional responsibilities may be assigned by Supervisor or Manager as needed to support the Organization.
Who You Are:
· An undergraduate degree in a biological science or equivalent life sciences degree is required.
· 1+ year experience working in a laboratory setting
· Experience with FDA QSRs cGMP, and ISO 13485 or other related industry standards preferred
· Knowledge and experience in IHC, ELISA and Bioburden preferred.
· Knowledge of SAP and/or SAP NEXT preferred.
Job Requisition ID: 192805
Career Level: C - Professional (1-3 years)
Working time model: full-time
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.
Job Segment: QC, ERP, Laboratory, SAP, Quality, Technology, Science